RF shielding cover for RF radiating applicator

ABSTRACT

A disposable cover for electromagnetic treatment applicators prevents undesired exposure to potentially harmful radiation. The cover is a pouch-like structure having a back surface constructed from RF shielding material, such as metallized polyethylene, which back surface faces opposite, or away from, the treatment area. A portion of the cover which faces the treatment area is constructed from material transmissive to RF radiation from the applicator. Securing means, such as adhesive strips, or interlocking edges close an open end to secure the applicator inside the cover and to prevent RF radiation through the closed end. In use, an applicator is inserted within the cover and positioned over the area to be treated with the RF transmissive material overlying the treatment area. When the applicator is activated, the generated electromagnetic energy exits the cover only through the RF transmissive material to the treatment area and the RF shielding material prevents exposure of the caregiver to potentially harmful radiation.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of an applicationentitled “Disposable Protective Cover for RF Treatment Apparatus” filedAug. 11, 2005 and assigned Ser. No. 11/202,728, which application is acontinuation of an application entitled “Cover for ElectromagneticTreatment Applicator”, filed Sep. 14, 2000 and assigned Ser. No.09/661,604, which application claims the benefit of priority to aprovisional application assigned Ser. No. 60/154,435, filed Sep. 17,1999.

FIELD OF THE INVENTION

The present invention relates to electromagnetic treatment devices, andmore particularly to an apparatus for covering an electromagnetic energytreatment applicator which protects the applicator from biohazards andprovides selective radio frequency (RF) shielding.

BACKGROUND OF THE INVENTION

Electrotherapy includes various means of applying an electric orelectromagnetic field to a wound area to facilitate growth andproliferation of new tissue, i.e., healing. In an earlier patentapplication filed by the present inventors, an electromagnetic treatmentdevice is disclosed. The device includes a pulsed electromagnetic energygenerator, a power level controller and one or more applicators. Eachapplicator is a pad comprising one or more etched copper printedcircuits laminated between insulating sheets of material having highdielectric properties. Sensing units, including an electromagneticsignal strength detector and an applicator-to-patient proximitydetector, are incorporated in each applicator and are in communicationwith the power level controller to provide for direct monitoring of teelectromagnetic energy field and precise control of the treatmentdosage. The applicators, which are constructed in a variety of shapesand sizes to best match the wound size and area on the patient, areplaced over, under or around a bandaged wound site. Since theapplicators are not disposable items, needs exist for apparatus whichprevent cross-contamination between patients.

In addition, electromagnetic treatment applicators remain in directcontact with the wound site during treatment. Thus, the patient, andpossibly the health care providers, are potentially exposed to theemitted radiation. Needs exist for apparatus which limit undesiredexposure of the patient and health care provider to the treatmentradiation.

Existing covers for radiation shielding and medical applications areunacceptable for use with electromagnetic treatment applicators, such asthe one described above. Typical covers for use in medical applicationsare disclosed in U.S. Pat. Nos. 3,942,023, 4,605,124 and 4,715,366.Examples of other devices which provide radiation shielding aredisclosed in U.S. Pat. Nos. 5,336,896 and 5,523,581. Needs exist forcovers for electromagnetic treatment applicators which are costeffective, disposable and easy to use.

Citation of the above documents is not intended as a admission that anyof the foregoing is pertinent prior art. All statements as to the dateor representation as to the contents of these documents is based on theinformation available to the applicants and does not constitute anyadmission as to the correctness of the dates or contents of thesedocuments. Further, all documents referred to throughout thisapplication are incorporated in their entirety by reference herein.

SUMMARY OF THE INVENTION

It should be apparent that there exists a need for facilitating the safeand effective treatment of patients with electromagnetic energy. It istherefore a primary object of the present invention to fulfill that needby providing a cost effective, easy to use, disposable cover for usewith an electromagnetic energy treatment applicator. The present coveris easy to affix to the treatment applicator, assists in easyapplication of the applicator to the patient, promotes the transmissionof RF energy waves to the patient while blocking the propagation ofthose waves in any other direction, and provides biohazard shielding forprotecting against the transmission of diseases between patients.Further, the cover is configured in a manner which integrates theelectromagnetic properties of the cover into the circuitry for thetreatment applicator, such that the applicator is not functional in theabsence of the cover, thereby providing additional safeguards that theintended treatment is safe and efficacious.

More particularly, the present invention is a disposable cover fordevices that are used for therapeutically treating humans with dosagesof electromagnetic energy. The cover includes RF shielding materialoriented toward the backside of the cover, opposite the treatment area.At least a portion of the cover which faces the treatment area isconstructed solely from non-shielding material. Securing means, such asadhesive strips or interlocking edges, are provided for securing theapplicator inside the cover and closing off any leaks. The cover alsoincludes portions which wrap around the cord leading from the applicatorto the generating unit.

In use, an electromagnetic treatment applicator is inserted into thepresent cover and positioned over the area to be treated, with the RFnon-shielding (RF transmissive) portion or window of the cover overlyingthe treatment area. In one embodiment, the dimensions of the window areformed by removing selected strips from the outer surface of the cover.Once assembled, the applicator/cover combination forms a closely matchedand tuned network for effecting a highly efficient RF output. Whenactivated, the generated electromagnetic energy only exits the coverthrough the RF transmissive portion or window, thereby preventingexposure of the patient or caregiver to potentially harmful radiation.

The present invention has immediate commercial market potential in thefield of chronic wound healing. Beyond that immediate market, thepresent invention may also be utilized in other treatment fields whereincreasing the rate of growth and proliferation of human or other livingcells is essential, including the treatment of bums and surgicallyimplanted skin or soft tissue grafts, sports and rehabilitationmedicine, post surgical repair, and neuronal/brain/spinal injury repairand regeneration. In addition to the medical treatment of soft tissue,the present invention has applications in the field of laboratorygrowth/manufacturing of skin grafts to be sold and use in varioussurgical settings, veterinary medicine and related fields.

These and further and other objects and features of the invention areapparent in the disclosure, which includes the above and ongoing writtenspecification, with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of the disposable cover;

FIG. 2 is a block diagram showing how the cover is configured tointegrate its electromagnetic properties into the circuitry of theapplicator; and

FIG. 3 is a plan view of the disposable cover with mating interlockingstructures.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, where like elements are designated bylike reference numerals throughout, FIG. 1 shows an apparatus, morefully described below, for covering an electromagnetic energy treatmentapplicator. Apparatus 1 includes a front sheet 3 and a back sheet 5.Edges of the sheets 3, 5 are sealed or otherwise connected to form apouch-like structure with an open end 7 for receiving an applicator (notshown). In alternative embodiments, the apparatus 1 is made from asingle sheet, which is folded and sealed such that it has an open end 7.The front sheet 3 (which faces the treatment area) is preferably made,at least partially, of a non-shielding material, such as transparentpolyethylene. The back sheet 5 (which faces opposite, or away from, thetreatment area) is preferably constructed entirely from shieldingmaterial, such as metallized polyethylene, thereby ensuring the blockageof unintended RF transmissions in nontreatment directions. One or morelight adhesive strips are located along the outer surface of the frontsheet 3 for affixing the cover 1 to a bandage. Preferably, the frontsheet 3 of the cover 1 has a patch of adhesive at its center forsecuring the applicator over the treatment area. The selected adhesiveis of low bonding force enabling easy separation from the matingsurface.

As shown in FIG. 1, a tab portion 11 extends from the front sheet 3.After the applicator is inserted in the cover 1 through its open end 7,tab portion 11 is folded over such that it overlies a section of theouter surface 13 of the back sheet 5. In one embodiment, an adhesivestrip 15 is provided along the outer surface 13 of the back sheet 5 forsecuring the tab portion 11 in its folded position. In anotherembodiment, tab portion 11 has a permanent adhesive strip whichpreferably runs the length of the unsealed end. It should be understoodthat other attachment means for securing the tab portion 11 in itsfolded position are contemplated by the present invention. Preferably,tab portion 11 includes a semi-circular notch 17 or other similaropening or spacing which allows a coaxial cable to protrude therethroughwhen the cover 1 is sealed. Tab portion 11 further includes perforations19, preferably provided along the length of the tab portion 11, forenabling easy removal. It should also be understood that, in yet anotherembodiment, tab portion 11 consists of interlocking means to connect itto a second tab portion extending along the top of front sheet 3. (FIG.3)

For additional biohazard protection, the tab portion 11 is extended,thereby allowing the tab portion 11 to be wrapped around the cable. Insuch embodiments, no notch is required. Rather, the extended tab portion11 is wrapped around the cable and secured thereto with adhesive locatedalong a surface of the tab portion. The tab portion is also secured tothe back sheet 5 to seal off entry to the interior of the cover 1 wherethe applicator is located.

It should be understood that the tab portion 11 can extend from the backsheet 5, as opposed to the front sheet 3, or from both the back sheet 5and the front sheet 3 without departing from the scope of the presentinvention. Other means for sealing off the open end of the cover 1,including, but not limited to, mating tabs, interlocking strips, orother fastening means, are also contemplated by the present invention.

In an alternative preferred embodiment, shown in FIG. 3, tab portionsextend from both the front sheet 3 and the back sheet 5. Matinginterlocking means 12 are located along each tab portion 11.

In its preferred form, the cover 1 is rectangular in shape andapproximately 10 inches by 12 inches in size. The thickness of the cover1 is approximately 1/100 of an inch. At least the outer surface of thecover 1 is waterproof and bacterial resistant, and is designed to beplaced directly on the patient or on top of any standard dressings usedover the area to be treated.

As described earlier, the cover 1 is composed of a combination of twotypes of materials—one selected for its properties of resistance totransmission of RF waves and one selected for its ability to bemechanically joined to the first material. Both materials are preferablyalso good barriers to moisture absorption, thereby preventing biohazardsfrom coming in contact with the applicator surfaces. The RF shieldingmaterial prevents emission from the applicator in any direction otherthan that to be focused at the wound site. The shielding enables the useof the electromagnetic treatment device while being compliant withstandards for transmission of radio frequency and other forms ofelectromagnetic energy.

In its simplest form, the front sheet 3 is made of a non-shieldingmaterial and the back sheet 5 is made of a shielding materia. It shouldbe understood, however, that variations of this embodiment are alsocontemplated by the present invention. For example, the entire cover canbe constructed of RF shielding material except for a window over thetreatment zone (the treatment zone is characterized as the area abovethe applicator transmitting antenna). In an alternative embodiment, theentire cover, or a portion thereof, can be constructed of non-shieldingmaterial, with strips of shielding material adhered thereto. Forexample, RF shielding material perforated in concentric circles, orother shapes, are bonded to the outer surface of the transparentmaterial. In such embodiments, the window over the treatment zone can bevariable in size, with the user able to peel off certain shieldingstrips to match the transmission region to that of the wound to betreated. Other variations are also considered within the scope of thepresent invention.

In preferred embodiments, proper placement of the cover 1 over theapplicator is required for the device to operate. Preferably, theapplicator (such as the one disclosed in the present applicants' earlierpatent application) incorporates RF shielding material as a capacitorwhich is part of the electronic tuning of the applicator. Without thecover, the applicator cannot be tuned, thus the electromagnetic energytreatment device will detect a fault and will not operate. In oneembodiment, as shown in FIG. 2, cover 1 includes a shielded side whichconveys a particular capacitance upon the circuitry enclosed within theapplicator. When the requisite capacitance is present, the applicatorsends an appropriate voltage signal to a previously described powergenerator device (described in earlier application filed by inventors),enabling the device. In the absence of the cover conveying the requisitecapacitance, the voltage signal remains outside of a predetermined rangeand the power generating device is disabled. In other words, the RFshielding provided by the cover acts as an additional source ofcapacitance (Y) which changes the final capacitance of system (Z). TheRF generating system is adjusted such that it is only operable when thecapacitance is within range provided by the capacitance within theinternal applicator pad shield circuitry (X) plus the capacitance (Y)provided by the cover.

The present invention is operated by placing the treatment applicatorinto the cover through its open end, with the treatment side of theapplicator oriented towards the front sheet and the coaxial cable of theapplicator protruding through the open end. A permanent adhesive peelstrip (which is located on the tab portion or the back sheet) isremoved, exposing the adhesive. Tab portion is folded over the end ofthe applicator, with the semi-circular cutout notch aligned with thecoaxial cable. The tab portion is then pressed against the back sheet tofully close the cover.

Where the cover includes an extended tab portion, there is nosemi-circular cable cutout. Rather the extended tab portion is foldedover and wrapped around the coaxial cable and bonded together to form abiohazard barrier. For further securement, a portion of the tab portionalso adheres to the back sheet.

Next, the peel strip material is removed from the outer surface of thefront sheet to expose a low bonding force adhesive. The coveredapplicator is aligned with the wound site. Indicia, such as printeddesigns, may be located on the outer surface of the front sheet forfacilitating proper alignment. The cover is then adhered to the bandagedwound site, thus ensuring proper location of the applicator to the woundsite. The adhesive is not permanent and can easily be pulled away fromthe bandaged site.

Following treatment, the cover is removed from the applicator andproperly disposed. Preferably, removal of the cover involves thefollowing steps. First, the cover is gripped at the two corners awayfrom the end with the protruding coaxial cable. Pulling the corners inopposite directions causes the cover to tear at the center. As the tearclears the cover can be removed from the applicator and disposed. Forembodiments including the extended tab portion, the user continues thetear the cover past the intersection of the applicator and cable untilthe cover can be removed.

From the foregoing, it will be appreciated by those skilled in the artthat the present invention provides a particularly effective andadvantageous method of and apparatus for overcoming many of thelimitations associated with the treatment of patients usingelectromagnetic energy. It will also be readily appreciated by one withordinary skill in the art to use the method and apparatus of the presentinvention in other applications, such as veterinary applications.

Although certain presently preferred embodiments of the presentinvention have been specifically described herein, it will be apparentto those skilled in the art to which the invention pertains thatvariations and modifications of the various embodiments shown anddescribed herein may be made without departing from the spirit and scopeof the invention.

1-7. (canceled)
 8. A system comprising: a radio frequency (RF)generator; an electromagnetic treatment applicator attached to the RFgenerator with a cable, the electromagnetic treatment applicator havinga first side and an opposite second side, wherein the first side is tobe positioned adjacent a treatment area; and a disposable coverconfigured to cover the electromagnetic treatment applicator, thedisposable cover having an open end, a front side, a back side, whereinthe open end is configured to permit insertion and removal of theelectromagnetic treatment applicator into and out of the disposablecover, wherein the front side is configured to be positioned adjacentthe first side of the electromagnetic treatment applicator when theelectromagnetic treatment applicator is inserted into the disposablecover, and wherein the back side is configured to be positioned adjacentthe second side of the electromagnetic treatment applicator when theelectromagnetic treatment applicator is inserted into the disposablecover.
 9. The system of claim 8, wherein at least a portion of the backside of the disposable cover includes an RF shielding material having acapacitance, wherein the electromagnetic treatment applicator isconfigured to detect the presence of the disposable cover based on thecapacitance.
 10. The system of claim 9, wherein the electromagnetictreatment applicator is configured to send a signal to the RF generatorto enable the RF generator when the presence of the disposable cover isdetected.
 11. The system of claim 10, wherein the RF generator isdisenable when the signal is not sent by electromagnetic treatmentapplicator.
 12. The system of claim 9, wherein the back side is formedentirely of RF shielding material.
 13. The system of claim 12, whereinthe RF shielding material is metallized polyethylene.
 14. The system ofclaim 8, wherein at least a portion of the front side of the disposablecover is formed of an RF non-shielding material, and wherein thebackside of the disposable cover is formed entirely of an RF shieldingmaterial.
 15. The system of claim 8, wherein the disposable coverincludes a tab portion configured to close the open end when theelectromagnetic treatment applicator is inserted into the disposablecover.
 16. The system of claim 15, wherein the tab portion includes anopening for the cable.
 17. The system of claim 15, wherein the tabportion includes fasteners to close the open end.
 18. A systemcomprising: a radio frequency (RF) generator; an electromagnetictreatment applicator attached to the RF generator with a cable; and adisposable cover configured to cover the electromagnetic treatmentapplicator, the disposable cover having an open end, a front side, aback side opposite the front side, wherein the open end is configured topermit insertion and removal of the electromagnetic treatment applicatorinto and out of the disposable cover, wherein at least a portion of theback side of the disposable cover includes an RF shielding materialhaving a capacitance, wherein the electromagnetic treatment applicatoris configured to detect the presence of the disposable cover based onthe capacitance.
 19. The system of claim 18, wherein the electromagnetictreatment applicator is configured to send a signal to the RF generatorto enable the RF generator when the presence of the disposable cover isdetected.
 20. The system of claim 19, wherein the RF generator isdisenable when the signal is not sent by electromagnetic treatmentapplicator.
 21. The system of claim 18, wherein the back side is formedentirely of RF shielding material.
 22. The system of claim 21, whereinthe RF shielding material is metallized polyethylene.
 23. The system ofclaim 18, wherein at least a portion of the front side of the disposablecover is formed of an RF non-shielding material, and wherein thebackside of the disposable cover is formed entirely of an RF shieldingmaterial.
 24. The system of claim 18, wherein the disposable coverincludes a tab portion configured to close the open end when theelectromagnetic treatment applicator is inserted into the disposablecover.
 25. A method of using an electromagnetic treatment device, theelectromagnetic treatment device having a radio frequency (RF) generatorand an electromagnetic treatment applicator attached to the RF generatorwith a cable, the electromagnetic treatment applicator having a firstside and a second side opposite the first side, the method comprising:inserting the electromagnetic treatment applicator into a disposablecover, the disposable cover having a front side and a back side oppositethe front side, wherein at least a portion of the front side includes anRF non-shielding material, wherein at least a portion of the back sideincludes an RF shielding material, wherein the electromagnetic treatmentapplicator is inserted to have the front side of the disposable coveradjacent to the first side of the electromagnetic treatment applicatorand the back side of the disposable cover adjacent to the second side ofthe electromagnetic treatment applicator; positioning theelectromagnetic treatment applicator with the first side of theelectromagnetic treatment applicator adjacent to a treatment area,wherein RF energy is applied to the treatment area through the firstside of the electromagnetic applicator, wherein the RF energy istransmitted through the portion of the front side of the disposablecover that includes RF non-shielding material, and wherein the RF energyis blocked by the portion of the back side of the disposable cover thatincludes RF shielding material; removing the electromagnetic treatmentapplicator from the disposable cover after the RF energy has beenapplied to the treatment area; and disposing the disposable cover afterremoving the electromagnetic treatment applicator from the disposablecover.
 26. The method of claim 25, wherein the electromagnetic treatmentapplicator is configured to detect the presence of the disposable coverbased on the capacitance, wherein the electromagnetic treatmentapplicator is configured to send a signal to the RF generator to enablethe RF generator when the presence of the disposable cover is detected,and wherein the RF generator is disenable when the signal is not sent byelectromagnetic treatment applicator.
 27. The method of claim 25,wherein the back side is formed entirely of RF shielding material.